Merit Medical Hero Graft Instrucciones De Uso página 2

INSTRUCTIONS FOR USE
Federal (USA) law restricts this device to sale by or on the order of a physician.
Only qualified healthcare providers should place, manipulate, de-clot, revise or explant the device.
Carefully read all instructions prior to use.
precautions
Adhere to universal when inserting, maintaining or explanting the device.
Not made with natural rubber latex.
STERILE (EO) – FOR SINGLE USE ONLY
Each component of the HeRO Graft is provided in double sterile barrier packaging and is EO sterilized in accordance with ISO 11135-1.
STORAGE
To provide maximum protection, store the HeRO Graft components in their original, unopened packages at room temperature. Keep dry and out of direct sunlight. Each
component must be used before the use by date printed on the individual labels.
Consult Instructions for Use
Prescription Device
Use-By Date
Do Not Re-Use
Sterilized Using Ethylene Oxide
Catalogue Number
Batch Code
Authorized Representative in the European
Community
DEVICE DESCRIPTION
He R O
The HeRO ( modialysis eliable utflow) Graft is a longterm access solution for access-challenged and catheter-dependent patients. HeRO Graft is a fully
subcutaneous surgical implant. It provides arterial venous (AV) access with continuous outflow into the central venous system.
The HeRO Graft traverses central venous stenosis allowing for long-term hemodialysis access.
Venous Outflow Component
5 mm ID
19F (6.3 mm) OD
Kink & crush resistant
nitinol reinforcement braid
Titanium
connector
HeRO Graft consists of two primary components:
Venous Outflow Component
• A proprietary
Arterial Graft Component
• A proprietary ePTFE
Venous Outflow Component
The HeRO Graft has a 5 mm inner diameter (ID), 19F outer diameter (OD), and is 40cm long. It consists of radiopaque silicone
with braided nitinol reinforcement (for kink and crush resistance) and a radiopaque marker band at the tip.
Arterial Graft Component
The HeRO Graft has a 6 mm ID, 7.4 mm OD, and is 53cm long, inclusive of the connector. It consists of an ePTFE hemodialysis
graft with PTFE beading to provide kink resistance near the titanium connector. The titanium connector has a tapered ID (6 mm to 5 mm) and attaches the
Graft Component Venous Outflow Component.
to the
technique according to KDOQI guidelines.
Accessory Component Kit
The provides instruments and accessories that may aid in the placement of the HeRO Graft.
The FDA regulation name for the HeRO Graft is vascular graft prosthesis.
INTENDED USE
The HeRO Graft is intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have exhausted peripheral venous access sites
suitable for fistulas or grafts.
INDICATIONS FOR USE
The HeRO Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-dependent patients are
readily identified using the KDOQI guidelines as patients who:
1
• Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options, such as arteriovenous fistulas and
grafts).
• Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or venography.
• Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography (e.g., fistula/graft salvage).
• Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography.
• Have a compromised central venous system or central venous stenosis (CVS) as determined by a history of previous access failures, symptomatic CVS (i.e., via arm,
neck, or face swelling), or venography.
• Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.
ENGLISH
DO NOT r
MR Conditional
Non-Pyrogenic
Do Not Resterilize
Manufacturer
Keep Dry
Keep Away from Sunlight
Do Not Use if Package is Damaged
40cm silicone-coated
outflow component
Radiopaque
marker band
53cm ePTFE
6 mm ID
7.4 mm OD hemodialysis
vascular graft
PTFE
beading
Arterial Graft Component
Arterial Graft Component
The HeRO Graft is cannulated using standard
2
2
CONTRAINDICATIONS
Implantation of the HeRO Graft is contraindicated if:
• The brachial or target artery inner diameter (ID) is less than 3 mm.
• The internal jugular vein (IJV) or target vasculature cannot be dilated to accommodate the 19F
HeRO Graft Venous Outflow Component.
• There is significant arterial occlusive disease that would preclude safe placement of an upper extremity
hemodialysis access.
• There is known or suspected allergy to device materials (i.e., ePTFE, silicone, titanium, nitinol).
esterilize.
• The patient has a topical or subcutaneous infection associated with the implantation site.
• The patient has known or suspected systemic infection, bacteremia or septicemia.
GENERAL WARNINGS
• Use of the HeRO Graft was clinically studied in the IJV. Implantation of the device in other vasculature has NOT been studied and may
increase the risk of adverse events not encountered in the clinical trial.
• DO NOT use product if package has been damaged, opened, or the use by date has passed, as sterility may be compromised.
• The HeRO Graft is a single use only product. DO NOT resterilize or reuse any component.
GENERAL CAUTIONS
• Only qualified healthcare practitioners should place, manipulate, cannulate, declot, revise or explant the device.
• The HeRO Graft is intended for use by physicians trained and experienced in endovascular and surgical interventions and techniques.
• Adhere to universal precautions when implanting, cannulating, maintaining or explanting the device.
• DO NOT place the HeRO Graft in the same vessel as a catheter, defibrillator or pacemaker lead.
• To avoid vessel damage, fluoroscopy must be used when inserting the HeRO Graft into the central venous system.
• Monitor the patient for signs of arrhythmia throughout the procedure. To minimize the risk of arrhythmia, DO NOT place the tip of the
guidewire into the right ventricle.
• Caution should be used when placing or removing the Venous Outflow Component where stent contact may occur due to the potential
for Venous Outflow Component or vessel damage.
• DO NOT use mechanical/rotational thrombectomy devices (e.g., Arrow-Trerotola PTD
connector as internal damage may occur to these components.
POTENTIAL COMPLICATIONS
The HeRO Graft provides an important means of treating patients requiring hemodialysis; however, the potential exists for serious complications
including, but not limited to the following:
Potential Vascular Graft & Catheter
Complications
• Seroma
• Infection
• Foreign body reaction or rejection
• Vascular graft revision / replacement
• Vascular insufficiency due to steal syndrome
• Partial stenosis or full occlusion of prosthesis or vasculature
• Superior Vena Cava Syndrome
• Prosthesis failure
• Device kinking or compression
• Site pain
• Device migration
• Anastomosis or wound dehiscence
• Pseudoaneurysm
• Edema
• Ectasia
• Abnormal healing / skin erosion
• Graft extravasation
Arterial
SUMMARY OF HeRO GRAFT CLINICAL EXPERIENCE
The HeRO Graft was evaluated in a prospective clinical study to demonstrate that the device raises no new concerns of safety and effectiveness when used as indicated
in patients requiring long-term hemodialysis.
The HeRO Graft was studied in two different patient populations. One was a prospective literature controlled study of HeRO Graft / implant procedure-related
bacteremia rates in catheter-dependent subjects (the "bacteremia study"),
subjects compared to subjects receiving an ePTFE control graft (the "patency study").
Fourteen (14) institutions treated 86 subjects with the HeRO Graft. Subjects were required to return for post-operative evaluation at three-month intervals for a
minimum of 12 months. Endpoint and performance results are summarized in
The study results show that the rate of device / procedure-related bacteremia associated with the HeRO Graft is statistically lower than reported in the literature for
tunneled catheters and comparable to that reported in the literature for conventional ePTFE grafts. HeRO Graft patency and adequacy of dialysis are significantly
improved compared to catheter literature and comparable to graft literature.
The HeRO Graft has an associated safety profile that is comparable to existing graft and catheters used for hemodialysis. In this study, no new concerns of safety and
effectiveness for a long-term vascular access device were observed. There were no unanticipated events. Serious HeRO Graft and / or procedure-related adverse events
Table 2
by type are summarized in
Device-related adverse events occurred at a frequency comparable to both the catheter and graft literature with the exception of bleeding.
events in the patency study, two (2) were indirectly related to the HeRO Graft implant procedure; in the first patient, coagulopathy was caused by other conditions
and bleeding was not unexpected, and in the second patient, a heparin administrative error occurred. Three (3) bleeding events were directly attributed to an earlier
generation 22F HeRO Graft Venous Outflow Component, which required an internal jugular venous cut-down. The sixth bleeding event was related to a HeRO Graft
explant procedure. There was one (1) device-related death in the patency study due to device-related sepsis complications, a known vascular access complication
reported in the literature. 4,5
ENGLISH
Potential Intraoperative & Post-Operative
Complications
• Reactions to anesthesia
• Respiratory / cardiac arrest
• Myocardial infarction
• Hypotension / hypertension
• Death
• Bleeding
• Hematoma
• Heart failure
• Cardiac arrhythmia
• Cardiac tamponade
• Sepsis
• Trauma to major vasculature or nerves
• Embolism
• Pneumothorax / hemothorax / hydrothorax
• Aneurysm
• Allergic reaction
3 and; the other was a randomized study of HeRO Graft patency in upper arm graft-eligible
3
Table 1
.
.
3
® ) in the Venous Outflow Component and/or
Of the six (6) bleeding
4,5